sNDAs Submitted for Xarelto for Treatment and Prevention of Recurrent Venous Thromboembolism

Janssen Research & Development announced that it has submitted supplemental New Drug Applications (sNDAs) to the FDA seeking approval for the use of Xarelto (rivaroxaban) to treat patients with deep vein thrombosis (DVT) or pulmonary embolism (PE) and prevention of recurrent venous thromboembolism (VTE).

These submissions are supported by data from the global EINSTEIN program, which included two Phase 3 studies that evaluated the safety and efficacy of rivaroxaban in the treatment of patients with acute symptomatic DVT or PE and the prevention of recurrent, symptomatic VTE in these patients. The third Phase 3 study evaluated the safety and efficacy of rivaroxaban in the long-term prevention of recurrent symptomatic VTE. In total, these Phase 3 studies included more than 9,400 patients.

Xarelto is a factor Xa inhibitor, oral anticoagulant. It is currently indicated for the prophylaxis of deep vein thrombosis in people undergoing knee- or hip-replacement surgery and for reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.